Non-invasive Biometric Monitoring in Nursing Homes to Fight COVID-19

Completed

• Conditions: Covid19; Community-Acquired Respiratory Tract Infection
• Interventions: Device: Observational measurement of biometric data. No change to health care provided.

• Registration Number: NCT04548895
• Lead Sponsor: Health Stream Analytics, LLC

Brief Summary

Solving the problem of detecting asymptomatic carriers who can transmit infection is key to protecting vulnerable residents of nursing homes and assisted living facilities, to protecting frontline workers who care for them, and to facilitating return to work (including return of nurses and medical assistants).

The wearable biometric technology, if widely disseminated among vulnerable populations and the community-at-large, will help avoid the ravages of seasonal flu and other contagious illnesses, and the society will be better prepared for future waves of COVID-19 or other pandemics. Even if a vaccine is developed, due to immune senescence and immunocompromise, elderly people and those with chronic medical conditions may not be well protected by it. Continuous biomonitoring provides another layer of protection for them.

Detailed Description

1. Building the algorithm for early, pre-symptomatic DETECTION OF RESPIRATORY VIRAL INFECTION and for predicting eventual DETERIORATION.

2. Create an APP that AUTOMATES these algorithms and clearly REPORTS ACTIONABLE RESULTS to users, i.e., to medical professionals and citizens-at-large in near-real time. If alerted to a possible - and likely still asymptomatic - COVID-19 infection, they can self-isolate or be quarantined, get confirmatory COVID-19 testing done promptly, limit transmission to others, and stay safe knowing that if they are likely to deteriorate, the algorithm will alert the participants and their caregivers to the need to obtain medical attention promptly.

Study Timeline

• Study First Submitted: 2020-09-10
• Study First Submitted QC: 2020-09-11
• Study First Posted: 2020-09-16
• Study Start: 2020-12-30
• Primary Completion: 2021-04-30
• Status Verified: 2021-06
• Study Completion: 2021-06-09
• Last Update Submitted: 2021-06-09
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Residents and staff members of U.S. LTCFs where COVID-19 transmission is actively occurring. The LTCF medical director must agree to enroll the LTCF, and each participant must have the capacity to agree and sign consent.

Exclusion Criteria

• Current atrial fibrillation.

  • NB: Paroxysmal atrial fibrillation is permitted if the participant is in atrial fibrillation less than 50% of the day on most days.

• Pacemaker in place.

• Known active infection other than COVID-19.

• Dementia

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LTCF residents and involved health practitioners	Observational measurement of biometric data. No change to health care provided.	The intervention will take place in nursing homes, assisted living facilities and long-term care facilities (LTCF) in the United States (henceforth collectively referred to as "LTCF"). Staff who work in the participating LTCF ≥ 20 hours/week and who have direct contact with the residents are also eligible to participate and to employ the biometric monitoring equipment in their private residences.

Primary Outcome Measures

Name	Time	Method
Predictive characteristics of the algorithm for respiratory tract infection	2 months	Algorithm development, sensitivity, specificity, positive and negative predictive value at different lead times ahead of symptom onset
Proportion of quality signals obtained out of all monitoring time for each device	8 weeks from first enrollment	Feasibility assessment

Trial Locations

Locations (1)

Avalon Health & Rehabilitation Center; 🇺🇸 Pasco, Washington, United States